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/---- / Offi-- - ated Information

Benjamin F. Blomeke, R.Ph. Radiation Safety Officer Hot Shots Nuclear Medicine 4025 West Main Suite 102 Kalamazoo, MI 49006

UNITED STATES NUCLEAR REGULATORY COMMISSION

REGION HI 2143 ‘$J/lRRCNVI!LEI ROAD SUITE 210

LISLE ILLINOIS 60532-4352

SEI’ 2 3 2010

Dear Mr. Blomeke:

Enclosed is Amendment No. 01 to your NRC Material License No. 21-32778-01 MD in accordance with your request.

Please review the enclosed document carefully and be sure that you understand all conditions. If there are any errors or questions, please notify the U S . Nuclear Regulatory Commission, Region I l l office at (630) 829-9887 so that we can provide appropriate corrections and answers.

Please note that, at this time, we were unable to approve the request to add Eric A. Lester, R.Ph. as an Authorized Nuclear Pharmacist (ANP) because the information in your letter dated June 22, 2010, was insufficient to complete our review.

If you wish to pursue this request, please submit the information below as a currently dated, signed written response, addressed to my attention as “additional information to control no. 573053.” We will then continue our review.

Mr. Lester was not approved as an ANP because the referenced license provided was only a one-page excerpt of an Agreement State license that we do not have access to; it was incomplete, unsigned and undated; it showed Mr. Lester as a Radiation Safety Officer (RSO) but the type of program was not included as only the one page of the license was provided and, more importantly, being named RSO does not qualify a person to become an ANP.

Mr. Lester also presented certain documents about his pharmacy training and experience as attachments to the June 22, 2010, letter. These documents showed that his training and experience were obtained more than seven years preceding the date of application. In your response please address how Mr. Lester meets the requirements for “Recentness of Training” in 10 CFR 35.59.

It would be best if Mr. Lester and his preceptor(s) completed an NRC Form 313a (ANP), which can be found on our website at:

Guidance to assist Mr. Lester in completing this form can be found in NUREG 1556, Vol. 9, Rev. 2, Appendix D, sections IV, V and Vlll.

It was unclear to us why the “Authorized User Status Review” dated August 12,2002 was submitted. It does not constitute a preceptor attestation, if that was the intended

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The enclosed document contains sensitive security-related information. When separated from this cover letter this letter is uncontrolled.

B. Blomeke

purpose, which is just speculation on our part. Please submit an appropriate preceptor attestation, in accordance with 10 CFR 35.55(b)(2).

The certificate showing that Mr. Lester completed the nuclear pharmacy certificate program on August 14, 2002, was insufficient to support his request also.

The “Nuclear Pharmacy Internship” record listing approximately 670 hours did not provide a breakdown of how those hours were spent to demonstrate compliance with 10 CFR 35.55(b)(l)(ii).

You may wish to refer to the above regulatory requirements, as well as section 8.13, item 7 and Appendices B, D and E in NUREG 1556, Vol. 9, Rev. 2, for assistance in preparing your response.

In addition, you may find the guidance in RIS 2003-17 helpful, found at this link on our webs i te :

http://www.nrc.gov/reading-rm/doc-collections/gen-comm/reg- issues/2003/ri200317.pdf

Please do not submit resumes, CV’s, copies of Radiation Safety Committee meeting minutes, broad scope license permit applications or personal, proprietary information that we must protect, in accordance with 10 CFR 2.390, such as social security numbers, dates of birth, home addresses or phone numbers, patient records, college transcripts, etc.

Please also be reminded of the provisions in 10 CFR 30.9(a), “Completeness and accuracy of information,’ ’...”(a) Information provided to the Commission by an applicant for a license or by a licensee or information required by statute or by the Commission’s regulations, orders, or license conditions to be maintained by the applicant or the licensee shall be complete and accurate in all material respects.”

Finally, please note that I deleted Condition No. 19, as it appeared on your original license, because it was no longer appropriate for your license. As a result, several of your license conditions have been renumbered and are shown in bold font. I also added Condition No. 13.F., which completes this Condition correctly.

If you have any questions concerning this amendment please contact me at (630) 829- 9841. My fax number is (630) 515-1078.

NRC’s Regulatory Issue Summary (RIS) 2005-31 provides criteria to identify security-related sensitive information and guidance for handling and marking of such documents. This ensures

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B. Blomeke ation

that potentially sensitive information is not made publicly available through ADAMS, the NRC’s electronic document system.

Pursuant to NRC’s RIS 2005-31 and in accordance with 10 CFR 2.390, the enclosed license document is exempt from public disclosure because its disclosure to unauthorized individuals could present a security vulnerability.

The RIS may be located on the NRC Web site at: http://www.nrc.gov/reading-rm/doc- collections/gen-comm/reg-issues/2005/ri200531 .pdf and the link for frequently asked questions regarding protection of security related sensitive information may be located at: http://www. nrc.gov/reading-rm/sensitive-info/faq.html.

A copy of this letter will be available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC’s document system (ADAMS). The NRC’s document system is accessible from the NRC Web site at h t t p : //www . n rc . go v/ rea d i n g - r m/a d a m s . h t m I (the P u b I i c E I e c t ro n i c Read i n g Room ) .

You will be periodically inspected by NRC. Failure to conduct your program in accordance with NRC regulations, license conditions, and representations made in your license application and supplemental correspondence with NRC will result in enforcement action against you. This could include issuance of a notice of violation, or imposition of a civil penalty, or an order suspending, modifying or revoking your license as specified in the General Statement of Policy and Procedure for NRC Enforcement Actions. Since serious consequences to employees and the public can result from failure to comply with NRC requirements, prompt and vigorous enforcement action will be taken when dealing with licensees who do not achieve the necessary meticulous attention to detail and the high standard of compliance which NRC expects of its licensees.

Colleen Carol Casey Mate ria Is Licensing Branch

License No. 21-32778-01 MD Docket No. 030-381 75

Enclosure:

Amendment No. 01